Needle with closure and method

ABSTRACT

A needle has a hollow shaft, a tip formed at one end of the shaft, one or more ports in fluid communication with the interior of the hollow shaft, and a closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s).

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 61/476,523, entitled“Filling Needle and Method,” filed Apr. 18, 2011, which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure.

FIELD OF THE INVENTION

The present invention relates to needles, and more particularly, relatesto filling needles and methods of filling with needles.

BACKGROUND INFORMATION

A typical prior art filling needle includes a hollow stainless steelshaft, a non-coring, conically-pointed tip fixedly secured to the distalend of the shaft, and diametrically opposed fluid ports proximal to thetip and in fluid communication between the interior of the shaft and theambient atmosphere. One drawback encountered with prior art fillingneedles is that the interior of the needle, and any fluid containedtherein, is exposed to the ambient atmosphere through the open fluidports. Even though the needle ports or eyes are very small, theincidence of contamination in aseptic filling is such that there stillcan be a need to control the environment in prior art filling machinesin order to protect the filling needles, and particularly the endopening(s) of the filling needles, regardless of type. If the ambientatmosphere is contaminated, the open ports can allow the interior of theneedle and any fluid passing therethrough to become contaminated. On theother hand, if the needle is used to dispense a contaminated fluid, or afluid that might be harmful if it is exposed to or comes into contactwith a person, the open ports can allow such fluid to contaminate itsambient atmosphere or potentially harm a person that contacts the needleor is in the vicinity thereof. In prior art filling machines, includingthe needle filling and laser resealing machines described in the presentinventor's U.S. Patent No. 6,604,561, the regulatory agencies requirecontrol of the needle environment in order to protect against anyexposure of the product itself to the environment and the resultingcontamination of the product that might occur. Accordingly, the surfacesthat may come into contact with the product, including the surfaces ofthe stopper and vial, are protected from the environment until theclosed vial is pierced by the sterile needle. But, if for whateverreason, the latter were to be contaminated, a risk of contaminating theproduct inside the vial would exist.

It is an object of the present invention to overcome one or more of theabove-described drawbacks and/or disadvantages of the prior art,including to reduce the risk of contamination and/or to reduce thecontrols over, or the need to control a filling needle environment.

SUMMARY OF THE INVENTION

In accordance with a first aspect, a needle comprises a hollow shaft; atip formed at one end of the shaft; a port in fluid communication withthe interior of the hollow shaft; and a closure. The closure and/or theshaft is movable between (i) a first position wherein the closure closesthe port, and (ii) a second position opening the port. To preventcontamination of the needle from external sources, the closure may beconfigured to provide a substantially fluid-tight and/or airtight orhermetic seal between the port and ambient atmosphere in the closedposition.

In some embodiments, the closure is biased in the direction from thesecond position to the first position to normally close the port. Insome such embodiments, the needle includes a biasing member, e.g., aspring, biasing the closure in the direction from the second position tothe first position.

In some embodiments, the closure is engageable with a penetrable septumto move the closure and/or the shaft from the first position wherein theclosure closes the port, to the second position opening the port, uponpenetrating the septum with the needle. In some such embodiments, atleast one of the closure and the shaft is movable from the secondposition wherein the port is opened, to the first position wherein theport is closed, during or upon withdrawing the needle from the septum.

In some embodiments, the closure extends annularly about the shaft. Insome embodiments, the closure includes a flange on one end thereofengageable with a biasing member or spring for biasing the closure inthe direction from the second position to the first position. Anopposite end of the closure is engageable with a stop surface of theneedle to stop the closure in the first position. In some embodiments, adistal end of the closure is substantially flush with an adjacentportion of the needle tip. In some embodiments, the tip is defined by anon-coring, conically-pointed tip.

In accordance with another aspect, a needle comprises first means forproviding a conduit for the passage of fluid therethrough; second meansformed at one end of the first means for penetrating a septum; thirdmeans in fluid communication with the conduit for passage of fluid fromthe conduit therethrough; and fourth means for closing the third means.The fourth means and/or the first means is movable between (i) a firstposition wherein the fourth means closes the third means, and (ii) asecond position opening the third means. In some embodiments, the firstmeans is a needle shaft, the second means is a needle tip, the thirdmeans is a port, and the fourth means is a closure.

In accordance with another aspect, a method comprising the followingsteps:

-   -   (i) piercing a septum with a needle and placing the needle in        fluid communication with a chamber;    -   (ii) during or after the piercing step, moving a closure and/or        a filling port of the needle from a closed position closing the        filling port to an open position opening the filling port; and    -   (iii) introducing fluid from the needle into the chamber after        full perforation of the septum and/or after the needle port(s)        or eye(s) have passed through the interior surface of the septum        and are located within the chamber.

In accordance with another aspect, the method further comprises thefollowing steps:

-   -   (iv) withdrawing the needle from the septum; and    -   (v) before and/or during the withdrawing step, moving the        closure and/or the filling port of the needle from the open        position to the closed position.

Some embodiments further comprise substantially sealing the filling portfrom ambient atmosphere in the closed position. Some embodiments furthercomprise substantially preventing any contact between the filling portand the septum during the penetrating and withdrawing steps. Some suchembodiments further comprise interposing the closure between the fillingport and septum to substantially prevent any contact between the fillingport and septum.

Some embodiments further comprise the step of sealing the resultingpenetration aperture in the septum. In these embodiments theself-closing properties of the septum material are engineered in amanner known to those of ordinary skill in the pertinent art based onthe teachings herein to prevent any opening or passage between theneedle and the pierced septum material, or any passage between theinterior of the filling machine and the sterile chamber of the containeror device to be filled after the septum is pierced. One objective and/oradvantage of such embodiments is to demonstrate that the sterilecontainer is always closed from its ambient environment even whenmechanically opened by the filling needle so that after piercing andwithdrawal of the needle, the visco-elastic or self-closing propertiesof the septum are such that any opening in the residual penetrationaperture would be less than or equal to about 0.05 micrometer, such asless than or equal to about 0.02 micrometer, or even less than or equalto about 0.01 micrometer, or otherwise at a size that prevents fluid,including air, from penetrating through the resulting penetrationaperture, prior to resealing thereof. In some such embodiments, thesealing step includes applying radiation or energy to the septum. Insome embodiments, the sealing step includes at least one of thermalsealing, laser sealing and liquid sealant sealing. An exemplary liquidsealant is silicone. In some such embodiments, the liquid silicone isover-molded onto a compatible septum and/or cap material to ensure sealintegrity and durability and enhance safety standards.

Some embodiments further comprise performing the penetrating, fillingand withdrawing steps in a non-sterile or relatively low sterilityassurance level (“SAL”) environment, such as about log 3 or lower,including about log 2 or about log 1; filling a sterile fluid throughthe needle and into the chamber; and maintaining the sterility of thefilled fluid throughout the penetrating, filling and withdrawing steps.Some embodiments further comprise sealing a resulting penetrationaperture in the septum and maintaining the sterility of the filled fluidduring the sealing step.

One advantage of the present invention is that the closure closes theneedle port(s) with respect to ambient atmosphere thereby preventingcontamination of the needle port and interior of the needle and, inturn, preventing contamination of fluid flowing therethrough. Anotheradvantage of certain embodiments is that they allow sterile fillingwithin a non-aseptic, non-sterile or relatively low SAL environment(e.g., about log 3 or lower) while nevertheless sterile filling fluidsinto containers or devices and hermetically resealing them. Accordingly,the filling of a non-preserved or preservative-free formulation with aself-closing filling needle of the present invention without control ofthe filling needle environment, or with reduced needle environmentcontrols, can be safer than filling a preserved formulation in anaseptically-controlled environment with prior art filling apparatus andmethods. Yet another advantage of some embodiments is that the closureis interposed between the needle port and a septum to prevent contactbetween the needle port and septum, and thereby further prevent anycontamination of the needle port and interior of the needle and of anyfluid flowing therethrough. In some embodiments, the combination of theself-closing needle, such as the needle with “sliding shutter” closure,and a liquid silicone drop (“LSD”) or other resealable septum, creates aunique system and method allowing for the reduction or elimination ofenvironmental controls required by prior art sterile filling systems andmethods, thereby allowing for a simplification in equipment, a reductionin the time associated with setup and operation of the equipment, and/ora reduction in the cost of equipment and/or aseptic filling andprocessing. As a consequence, devices and methods of the inventionfacilitate the ability of manufacturers of any size, including smallentity manufacturers, to safely fill preserved or preservative-freeformulations into aseptic environments, and to do so at a lower cost,with improved efficiency and/or in less time, than required by prior artaseptic filling devices and methods.

Other objects and advantages of the present invention, and/or of thecurrently preferred embodiments thereof, will become more readilyapparent in view of the following detailed description and theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sequential, cross-sectional view of a needle showing theseparate components of the needle, and the assembly thereof; and

FIGS. 2A through 2E are sequential cross-sectional views of the needleof FIG. 1 showing the needle during penetration of and withdrawal from aresealable septum for filling a device or chamber of a device throughsuch resealable septum.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In FIGS. 1 and 2, a needle is indicated generally by the referencenumeral 10. The needle 10 comprises a hollow shaft 12, a tip 14 formedat one end of the shaft; two ports 16, 16 in fluid communication withthe interior of the hollow shaft 12, and a closure 18. In theillustrated embodiments, the two ports 16 are diametrically opposedrelative to each other; however, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, theneedle may define any number of ports that may define any of numerousdifferent configurations and locations. The closure 18 and/or the shaft12 is movable between (i) a first position wherein the closure closesthe ports 16, as shown typically in FIG. 1, and (ii) a second positionopening the ports 16, as shown typically in FIG. 2C. In the illustratedembodiment, when in the closed position, the closure 18 forms asubstantially fluid-tight seal between the ports 16 and ambientatmosphere. The closure 18 is biased in the direction from the second oropen position to the first or closed position to normally close theports 16. In the illustrated embodiment, the needle 10 includes a coilspring 20 that biases the closure in the direction from the second oropen position to the first or closed position. As may be recognized bythose of ordinary skill in the pertinent art based on the teachingsherein, the closure may be biased in any of numerous different ways thatare currently known or that later become known, using biasing membersother than springs, and if a spring is used, any of numerous differentsprings or combinations of springs may be used. In the illustratedembodiment, the closure 18 is an axially or vertically sliding “shutter”closure that slides axially over the needle shaft 12 between thenormally closed and open positions. However, as may be recognized bythose of ordinary skill in the pertinent art based on the teachingsherein, the closure may take any of numerous different configurationsthat are currently known, or that later become known, for performing thefunction of the closure as described herein.

The closure 18 extends both annularly and axially about the shaft 12 andis slidably mounted on the shaft. The closure 18 includes an annularflange 22 on one end thereof that is engageable with the spring 20 forbiasing the closure in the direction from the second or open position tothe first or closed position. An opposite end 24 of the closure 18 isengageable with an annular stop surface 26 of the needle tip to stop theclosure in the first or closed position. The distal end 24 andsubstantially cylindrical body of the closure 18 are substantially flushwith the perimeter of the stop surface 26 and adjacent portion of theneedle tip 14. The annular flange 22, on the other hand, projectsradially outwardly to provide a surface for seating and engaging thedistal end of the spring 20. In the illustrated embodiment, the needletip 14 is defined by a non-coring, conically-pointed tip; however, asmay be recognized by those of ordinary skill in the pertinent art basedon the teachings herein, the needle tip may define any of numerous otherneedle tip configurations that are currently known, or that later becomeknown, such as a trocar tip. In one configuration, the spring force ofthe spring 20 is sufficient to allow the needle to penetrate the septumwhile maintaining the closure 18 in the closed position duringpenetration of the closure through the septum and until the annularflange 22 of the closure engages an exterior surface of the septum (orother exterior or stop surface of the device) to cause relative movementof the closure and shaft against the bias of the spring from thenormally closed position to the open position and, in turn, expose thesterile needle ports to the sterile device chamber.

An axially-elongated flange 28 includes bosses 30 that are receivedwithin corresponding apertures 32 formed in the needle shaft 12 tofixedly secure the flange to the shaft. A needle holder 34 is secured tothe flange 28 and includes a barbed fitting 36 for attachment to afilling line (not shown). In the illustrated embodiment, the flange 28is over-molded to the end of the shaft 12, and the needle holder 34 isover-molded to the flange 28. The coil spring 20 is mounted between thedistal end of the axially-elongated flange 28 and the closure annularflange 22. As may be recognized by those of ordinary skill in thepertinent art based on the teachings herein, any of numerous differenttypes of fittings or connections that are currently known, or that laterbecome known, equally may be employed for connecting the needle to afilling or other type of line or conduit.

As shown typically in FIG. 2, the needle 10 may be used to asepticallyor sterile fill fluids through a penetrable septum 38 into a chamber 40of a container or other device (not shown). As shown in FIG. 2A, priorto penetrating the septum 38, and when the needle tip 14 is exposed tothe ambient atmosphere, the closure 18 is in the closed position sealingthe ports 16 with respect to ambient atmosphere to thereby maintain thesterility of the ports and of the interior of the needle. As shown inFIG. 2B, upon penetrating the septum 38, the closure 18 is interposedbetween the ports 16 and the septum 38 to substantially prevent contactbetween the ports and the septum. Then, as shown in FIG. 2C, when theports 16 are located within the chamber 40, the annular flange 22 of theclosure engages the septum, and/or the frictional engagement between thecylindrical body of the closure 18 and the septum 38, prevents furthermovement of the closure relative to the septum. Further penetration ofthe needle 10 into the septum 38 causes the shaft 12 and needle tip 14to move relative to the closure 18 against the bias of the spring 20 to,in turn, move the ports 16 to the open position. In the open position ofFIG. 2C, the fluid within the needle is permitted to flow through theopen ports 16 and into the chamber 40. Since the sterile ports 16 arenot exposed to the ambient atmosphere, the ports, interior of theneedle, and fluid flowing therethrough, are not contaminated and/or aremaintained sterile as the fluid is injected or otherwise dispensed intothe chamber 40. After the chamber 40 is filled as desired, and as showntypically in FIG. 2D, the needle 10 is withdrawn from the septum 38. Asthe needle is withdrawn, the spring 20 biases the closure 18 downwardlyor in the direction of the septum 38. Therefore, as the needle shaft 12is withdrawn, it is moved axially relative to the closure 18 to, inturn, move the ports 16 into the closed position behind the closure. Thesliding shutter or closure 18 may be configured to substantially preventcontact between the needle eyes or ports 16, and the sliding shutter orclosure is closed over the needle eyes or ports prior to their passagethrough the septum and/or withdrawal therefrom. When the end 24 of theclosure 18 engages the stop surface 26 of the needle tip, the closure isfixed in the closed position, and is maintained in the closed positionby the downward force or bias of the spring 20. Thus, during and upon,and/or before, withdrawal of the needle 10 from the septum 38, theclosure 18 closes the ports 16 and prevents any contamination of theports or interior of the needle. In some embodiments, the septum 38 isengineered to self-close and thereby ensure that the head loss left bythe residual needle aperture 42 after the tip of the needle is withdrawnprevents any fluid ingress therethrough.

As shown typically in FIG. 2E, although the septum may be self-closingas described above, the resulting needle or penetration aperture 42 inthe septum may be resealed by a further process. Such processes includemechanically (such as by an overlying cover (not shown)), by applyingradiation or energy to the septum, e.g., thermal resealing, by laserresealing, or by applying a liquid sealant thereto, which may be curedat room temperature or by applying radiation or energy to the sealant,such as a silicone or silicon-based sealant, e.g., UV (ultraviolet) orvisible light curable composition, to form a fluid tight or hermeticseal and thereby maintain the sterility of the filled fluid in thechamber. Examples of resealable septums and processes for resealing themare described, for example, in the following patents and applicationsthat are incorporated by reference in their entirety herein: U.S. patentapplication Ser. No. 08/424,932, filed Apr. 19, 1995, entitled “Processfor Filling a Sealed Receptacle under Aseptic Conditions,” issued asU.S. Pat. No. 5,641,004; U.S. patent application Ser. No. 09/781,846,filed Feb. 12, 2001, entitled “Medicament Vial Having a Heat-SealableCap, and Apparatus and Method for Filling Vial,” issued as U.S. Pat. No.6,604,561, which, in turn, claims priority from U.S. Provisional PatentApplication Ser. No. 60/182,139, filed Feb. 11, 2000, entitled“Heat-Sealable Cap for Medicament Vial;” U.S. patent application Ser.No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers andMethods of Making and Filling Same,” issued as U.S. Pat. No. 7,100,646,which, in turn, claims priority from similarly titled U.S. ProvisionalPatent Application Ser. No 60/408,068, filed Sep. 3, 2002; U.S. patentapplication Ser. No. 10/766,172, filed Jan. 28, 2004, entitled“Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Methodfor Filling the Vial,” issued as U.S. Pat. No. 7,032,631, which, in turnclaims priority from similarly titled U.S. Provisional PatentApplication Ser. No. 60/443,526, filed Jan. 28, 2003 and similarlytitled U.S. Provisional Patent Application Ser. No. 60/484,204, filedJun. 30, 2003; U.S. Provisional Patent Application entitled “ModularFilling Apparatus and Method,” filed Apr. 13, 2012; U.S. patentapplication Ser. No. 12/901,420, entitled “Device with Co-MoldedClosure, One-Way Valve and Variable Volume Storage Chamber and RelatedMethod,” filed Oct. 8, 2010, which, in turn, claims priority tosimilarly titled U.S. Provisional Patent Application Ser. No.61/250,363, filed Oct. 9, 2009. The process then may be repeated wherebythe same needle 10 may be used to aseptically or sterile fill plural ornumerous chambers of devices.

When filling a sterile product, the self-closing septum 38 prevents thefilled product from being contaminated by the device environment. Inother applications, the self-closing septum prevents the product itselffrom contaminating its environment. For example, some products, such ascytotoxic products for treating cancer, or radioactive products, arehazardous and/or can be dangerous to operators, treatment professionalsor other persons that might need to handle the filling machine or filleddevices. Prior art equipment for handling such dangerous substances canbe complex and costly. One advantage of the self-closing needletechnology of the present invention is that it allows such dangerous orhazardous products to be filled and handled in a relatively safe andless costly manner than encountered in the prior art.

In another embodiment, the filling machine includes a first needle forpiercing the septum (not shown), and a second self-closing needle forpiercing the septum through the resulting penetration aperture formed bythe first needle. In this embodiment, the first needle may be a solidneedle without any lumen or closure, and may define a different diameterthan the second needle, such as a smaller diameter. The first needle maybe located in a first station and the second needle may be located in asecond station, wherein the devices with septums are transported fromthe first station to the second station on a motorized conveyor. Eachstation may include an over pressure of sterile air or other gas.Alternatively, the first and second needles may be located in the samestation on a common manifold or fixture to reduce the system footprintand/or to facilitate alignment of the second needle with the penetrationaperture of the first needle. As described above, the septum is formedof a visco-elastic material that self-closes after withdrawal of eachneedle therefrom, and therefore prevents any contamination of theinterior of the device between the first and second needle penetrations,and between the second needle penetration and resealing of the resultingpenetration aperture. One advantage of this embodiment is that thepenetration aperture formed by the first needle reduces that frictionalforce encountered by the second needle and closure during passagethrough the septum, and therefore reduces the spring force required tomaintain the closure in the normally closed position during septumpenetration.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous changes and modifications may bemade to the above-described and other embodiments of the presentinvention without departing from its scope as defined in the appendedclaims. For example, the needle, closure, spring of biasing member andholder may be made of any of numerous different metals or plastics thatare currently known or that later become known. The term “needle” isused herein to mean any of numerous different types of devices that areused to penetrate and introduce matter into, or withdraw matter from, anobject, such as a chamber or device, that are currently known, or thatlater become known. The term “septum” is used herein to mean any ofnumerous different types of needle penetrable septums, stoppers or otherdevices that are penetrable by a needle for filling a chambertherethrough. The needles may be used in sterile or non-sterileenvironments, to needle fill with or in accordance with any of numerousdifferent filling devices or methods that are currently known, or thatlater become known. Accordingly, this detailed description ofembodiments is to be taken in an illustrative, as opposed to a limitingsense.

1. A needle comprising: a hollow shaft; a tip formed at one end of theshaft; at least one port in fluid communication with the interior of thehollow shaft; and a closure; wherein at least one of the closure and theshaft is movable between (i) a first position wherein the closure closesthe at least one port, and (ii) a second position opening the at leastone port.
 2. A needle as defined in claim 1, wherein in the firstposition, the closure forms a substantially fluid-tight seal between theat least one at least one port and ambient atmosphere.
 3. A needle asdefined in claim 1, wherein the closure is biased in the direction fromthe second position toward the first position to normally close the atleast one port.
 4. A needle as defined in claim 3, further including abiasing member biasing the closure in the direction from the secondposition to the first position.
 5. A needle as defined in claim 3,wherein the closure is engageable with a penetrable septum to move atleast one of the closure and the shaft from the first position whereinthe closure closes the at least one port, to the second position openingthe at least one port, upon penetrating the septum with the needle.
 6. Aneedle as defined in claim 5, wherein at least one of the closure andthe shaft is movable from the second position wherein the at least oneport is opened, to the first position wherein the at least one port isclosed, during or upon withdrawing the needle from the septum.
 7. Aneedle as defined in claim 1, wherein the closure extends annularlyabout the shaft.
 8. A needle as defined in claim 1, wherein the closureincludes a flange on one end thereof engageable with a biasing memberfor biasing the closure in the direction from the second position to thefirst position.
 9. A needle as defined in claim 8, wherein an end of theclosure opposite the flange is engageable with a stop surface of theneedle to stop the closure in the first position.
 10. A needle asdefined in claim 1, wherein a distal end of the closure is substantiallyflush with an adjacent portion of the needle tip.
 11. A needle asdefined in claim 1, wherein the tip is defined by a non-coring,conically-pointed tip.
 12. A needle as defined in claim 1, furthercomprising a holder connected to an end of the shaft opposite the tipand engageable in fluid communication with a filling line forintroducing fluid from the filling line through the needle.
 13. A needleas defined in claim 12, wherein the holder is over-molded to the shaft.14. A needle comprising: first means for providing a conduit for thepassage of fluid therethrough; second means formed at one end of thefirst means for penetrating a septum; third means in fluid communicationwith the conduit for passage of fluid from the conduit therethrough; andfourth means for closing the third means, wherein at least one of thefourth means and the first means is movable between (i) a first positionwherein the fourth means closes the third means, and (ii) a secondposition opening the third means.
 15. A needle as defined in claim 14,wherein the first means comprises a needle shaft, the second meanscomprises a needle tip, the third means comprises at least one port, andthe fourth means comprises a closure.
 16. A method comprising thefollowing steps: piercing a septum with a needle and placing the needlein fluid communication with a chamber; prior to or during the piercingstep, moving at least one of a closure and at least one filling port ofthe needle from a closed position closing the at least one filling portto an open position opening the at least one filling port; andintroducing fluid from the needle into the chamber.
 17. A method asdefined in claim 16, further comprising the following steps: withdrawingthe needle from the septum; and before or during the withdrawing step,moving at least one of the closure and the at least one filling port ofthe needle from the open position to the closed position.
 18. A methodas defined in claim 17, wherein the fluid is introduced from the needleinto the chamber after full perforation of the septum or after part ofthe at least one filling port has passed through an interior surface ofthe septum and is located within the chamber.
 19. A method as defined asdefined in claim 18, wherein the fluid is introduced from the needleinto the chamber after the at least one filling port is substantiallycompletely located within the chamber.
 20. A method as defined in claim17, further comprising substantially sealing the at least one fillingport from ambient atmosphere in the closed position.
 21. A method asdefined in claim 17, wherein during the penetrating and withdrawingsteps, substantially preventing any contact between the at least onefilling port and the septum.
 22. A method as defined in claim 21,further comprising interposing the closure between the at least onefilling port and septum to substantially prevent any contact between theat least one filling port and septum.
 23. A method as defined in claim17, further comprising the step of sealing a resulting penetrationaperture in the septum.
 24. A method as defined in claim 23, wherein thesealing step includes applying radiation or energy to the septum,thereby sealing the penetration aperture.
 25. A method as defined inclaim 23, wherein the sealing step includes at least one of thermalsealing, laser sealing and liquid sealant sealing.
 26. A method asdefined in claim 25, wherein the liquid sealant is silicone.
 27. Amethod as defined in claim 17 further comprising performing thepenetrating, filling and withdrawing steps in a non-sterile environmentor an environment defining a SAL of about log 3 or less; filling asterile fluid through the needle and into the chamber; and maintainingthe sterility of the filled fluid throughout the penetrating, fillingand withdrawing steps.
 28. A method as defined in claim 27, furthercomprising sealing a resulting penetration aperture in the septum andmaintaining the sterility of the filled fluid during the sealing step.29. A method as defined in claim 17, further comprising piercing theseptum with a first needle and withdrawing the first needle to create aresulting penetration aperture within the septum, and then performingsaid piercing step with said needle including the closure through thepenetration aperture formed by the first needle.
 30. A method as definedin claim 29, wherein the septum is self closing and substantiallyprevents the ingress of fluid through the resulting penetrationaperture.